CALAMINE LOTION BP
Active substance: ZINC OXIDE
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients Calamine Zinc Oxide BP Ph Eur
% w/v 15 5
3
PHARMACEUTICAL FORM
Lotion
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of minor skin rashes and irritation.
4.2
Posology and method of administration Adults, children and elderly To be applied when required to the affected area. For topical application.
4.3
Contraindications Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use Shake the bottle. For external use only. Keep all medicines out of the reach of children.
4.5
Interaction with other medicinal products and other forms of interaction No clinically significant interactions known. May mask x-ray pictures under certain circumstances.
4.6
Fertility, pregnancy and lactation The safety of Calamine Lotion during pregnancy and lactation has not been established but used during these periods is not considered to constitute a hazard.
4.7
Effects on ability to drive and use machines No adverse effects known.
4.8
Undesirable effects Occasional hypersensitivity or irritant reactions.
4.9
Overdose If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Calamine has a mild astringent action on the skin.
5.2
Pharmacokinetic properties None known.
5.3
Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Bentonite Glycerol Sodium Citrate Phenol Water Purified
6.2
Incompatibilities None stated.
6.3
Shelf life 36 months.
6.4
Special precautions for storage None.
6.5
Nature and contents of container A white flint glass bottle with an unlined polypropylene cap. An amber glass bottle with vinyl seal faced compocork in thermoset plastic cap. Alternative cap: Aluminium roll-on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner. Pack sizes: 200, 2000 millilitres.
6.6
Special precautions for disposal None stated.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
Almus
8
MARKETING AUTHORISATION NUMBER(S)
PL 00014/5471R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 31 October 1984 Date of Last Renewal: 23 January 1996
10
DATE OF REVISION OF THE TEXT
10/05/2012
Calamine Lotion BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients Calamine Zinc Oxide BP Ph Eur
% w/v 15 5
3
PHARMACEUTICAL FORM
Lotion
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of minor skin rashes and irritation.
4.2
Posology and method of administration Adults, children and elderly To be applied when required to the affected area. For topical application.
4.3
Contraindications Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use Shake the bottle. For external use only. Keep all medicines out of the reach of children.
4.5
Interaction with other medicinal products and other forms of interaction No clinically significant interactions known. May mask x-ray pictures under certain circumstances.
4.6
Fertility, pregnancy and lactation The safety of Calamine Lotion during pregnancy and lactation has not been established but used during these periods is not considered to constitute a hazard.
4.7
Effects on ability to drive and use machines No adverse effects known.
4.8
Undesirable effects Occasional hypersensitivity or irritant reactions.
4.9
Overdose If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Calamine has a mild astringent action on the skin.
5.2
Pharmacokinetic properties None known.
5.3
Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Bentonite Glycerol Sodium Citrate Phenol Water Purified
6.2
Incompatibilities None stated.
6.3
Shelf life 36 months.
6.4
Special precautions for storage None.
6.5
Nature and contents of container A white flint glass bottle with an unlined polypropylene cap. An amber glass bottle with vinyl seal faced compocork in thermoset plastic cap. Alternative cap: Aluminium roll-on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner. Pack sizes: 200, 2000 millilitres.
6.6
Special precautions for disposal None stated.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
Almus
8
MARKETING AUTHORISATION NUMBER(S)
PL 00014/5471R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 31 October 1984 Date of Last Renewal: 23 January 1996
10
DATE OF REVISION OF THE TEXT
10/05/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
